FDA ends 2023 on high note for GI: Ulcerative colitis pipeline teeming with new approvals
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In the second half of 2023, there were numerous landmark FDA approvals for gastroenterology and hepatology, in particular for the treatment of ulcerative colitis, with four new options squeezing into an already saturated market.
Within the last few months, the agency has approved several “first and only” UC therapies, including Eli Lilly’s trailblazing IL-23p19 inhibitor, Omvoh (mirikizumab), Pfizer’s Velsipity (etrasimod) as a second S1P receptor modulator and two subcutaneous formulation offerings: Takeda Pharmaceuticals’ Entyvio (vedolizumab) and Celltrion USA’s Zymfentra (infliximab-dyyb).
Image: Healio
With these newly approved UC therapies battling for market share against established heavyweights like Stelara (ustekinumab, Janssen), Humira (adalimumab, AbbVie) and Xeljanz (tofacitinib, Pfizer), the stage is set for a shake-up in the UC treatment landscape in 2024.
In addition, despite its initial rejection earlier in 2023, the FDA has greenlit treatments for erosive esophagitis, or erosive gastroesophageal reflux disease, and Helicobacter pylori infection and more.
Healio continues to closely monitor FDA decisions, reporting on approvals awaited by the GI community as well as other important up-to-date information from the agency. In case you missed any of it, Healio recaps the FDA’s latest gastroenterology and hepatology news below.
Mirikizumab rebounds to win FDA approval as first IL-23p19 agonist for ulcerative colitis
The FDA has approved Eli Lilly’s Omvoh infusion/injection as the “first and only” interleukin-23p19 antagonist for the treatment of patients with moderately to severely active ulcerative colitis, according to a company release.
The agency had denied Eli Lilly’s biologic license application for Omvoh (mirikizumab-mrkz) for this indication earlier this year, citing only concerns over the proposed manufacturing of the drug rather than the clinical data package, safety or label. Read more.
FDA approves Zymfentra as first subcutaneous infliximab for ulcerative colitis, Crohn’s
The FDA approved the subcutaneous formulation of Celltrion USA’s Zymfentra as maintenance therapy for patients with moderately-to-severely active ulcerative colitis and Crohn’s disease following induction with IV administered infliximab.
Zymfentra (infliximab-dyyb) is now “the first and only” subcutaneous formulation of infliximab approved for this indication, according to a company press release. The IV formulation of the Celltrion’s infliximab biosimilar was originally approved by the EU in 2013 under the name Remsima for the treatment of eight autoimmune diseases, including Crohn’s disease and ulcerative colitis, and later approved by the FDA in 2016. In the U.S., it is manufactured by Celltrion and marketed by Pfizer as Inflectra. Read more.
FDA approves Pfizer’s Velsipity as ‘oral, once-daily pill’ for ulcerative colitis
The FDA has approved Pfizer’s 2 mg once-daily Velsipity, an oral, selective sphingosine-1-phosphate receptor modulator, to treat adult patients with moderately to severely active ulcerative colitis, according to a company press release.
This approval designates Velsipity (etrasimod) as only the second S1P receptor modulator available for the treatment of UC since Zeposia (Ozanimod, Bristol Myers Squibb) was approved for the indication in 2021. Read more.
Voquezna back on track with FDA approval for erosive esophagitis, heartburn relief
The FDA has approved Phathom Pharmaceuticals’ Voquezna tablets 10 mg and 20 mg to treat erosive esophagitis, or erosive gastroesophageal reflux disease, and alleviate heartburn associated with the disease, noted a company release.
This decision comes after the agency had rejected Phathom’s new drug application for Voquezna (vonoprazan) in February, citing the presence of nitrosamine impurities. The FDA had requested that the company provide “additional stability data to demonstrate that levels” of the impurity would remain at or below the daily acceptable intake throughout the shelf life of the product. Read more.
FDA approves reformulated Voquezna Triple, Dual Pak for H. pylori infection
The FDA has approved the prior approval supplement for Phathom Pharmaceutical’s reformulated vonoprazan tablets for its Voquezna Triple Pak and Voquezna Dual Pak to treat adults with Helicobacter pylori infection, according to a company release.
This decision comes after the agency had rejected Phathom’s post-approval supplement for H. pylori in February, citing the presence of nitrosamine impurities. The FDA had requested that the company provide “additional stability data to demonstrate that levels” of the impurity would remain at or below the daily acceptable intake throughout the shelf life of the product. Read more.
FDA approves subcutaneous Entyvio as maintenance therapy for ulcerative colitis
The FDA has approved subcutaneous administration of Takeda Pharmaceuticals’ Entyvio for maintenance therapy in adult patients with moderate-to-severe ulcerative colitis following induction therapy via IV administration of the biologic.
The IV formulation of Entyvio (vedolizumab, Takeda Pharmaceuticals) was approved in 2014 for both moderate-to-severe UC and Crohn’s disease. The company noted that the new formulation of Entyvio is expected to be available as single-dose pre-filled pen within the next month. Read more.
FDA grants fast track status to monoclonal antibody for primary sclerosing cholangitis
The FDA has granted fast track designation to Chemomab Therapeutics’ anti-CCL24 monoclonal antibody, CM-101, for the treatment of adults with primary sclerosing cholangitis, according to a manufacturer release.
In preclinical and clinical studies, CM-101, a first-in-class CCL24-neutralizing monoclonal antibody, has been linked to crucial pathways in underlying primary sclerosing cholangitis pathophysiology. Chemomab noted that the antibody’s dual anti-inflammatory/anti-fibrotic activity is intended to “break the vicious cycle driving these pathways,” and has shown promise as a disease-modifying therapy for PSC-related processes in preclinical/early clinical studies. Read more.
FDA grants MR conditional use to Enterra’s electrical stimulation device for gastroparesis
The FDA has granted conditional use with magnetic resonance imaging to Enterra Medical’s implantable electrical stimulation device for management of symptoms associated with gastroparesis, according to a company release.
The Enterra II system, specifically its component parts Enterra 37800 Neurostimulator and Enterra Therapy 4351-35 unipolar leads, is intended to relieve symptoms associated with gastroparesis, including nausea and vomiting, the company noted. The system uses gastric electrical stimulation to deliver electrical pulses to the nerves and smooth stomach muscles to control symptoms. Read more.
FDA grants de novo status to ‘5-minute’ drug monitoring tests for Humira, Remicade in IBD
The FDA has granted de novo clearance to ProciseDx Inc. for its therapeutic drug monitoring tests for Humira and Remicade, as well as their biosimilars, in patients with inflammatory bowel disease, according to a company release.
These are the first therapeutic drug monitoring tests authorized by the FDA for Humira (adalimumab, AbbVie) and Remicade (infliximab, Janssen) biologic therapies, in addition to the biosimilars Amjevita (adalimumab-atto, Amgen), Inflectra (infliximab-dyyb; Celltrion/Pfizer) and Renflexis (infliximab-abda, Samsung and Organon). Read more.
FDA approves ‘more flexible Talicia regimen’ of three daily doses for H. pylori infection
The FDA approved the supplemental new drug application for Talicia for Helicobacter pylori eradication, shortening the current dosing regimen to improve patient adherence, according to manufacturer RedHill Biopharma.
According to a company press release, the dosing regimen for Talicia (omeprazole magnesium, amoxicillin and rifabutin) has been updated to three times daily, taken at least 4 hours apart with food compared with the previous dosing of every 8 hours. The new dosing regimen follows a “breakfast, lunch and dinner” routine that may enhance patient adherence and improve H. pylori eradication efforts, the company noted. Read more.
FDA approves Veklury as first antiviral COVID-19 treatment for all liver disease stages
The FDA expanded its approval of Gilead Sciences’ antiviral, Veklury, for the treatment of COVID-19 in patients with mild, moderate and severe hepatic impairment, without requiring dose adjustments, according to a manufacturer release.
Gilead noted that this approval supports the safety profile of Veklury (remdesivir, Gilead Sciences) “as the first and only approved antiviral COVID-19 treatment that can be used across all stages of liver disease.” The FDA’s expanded indication of Veklury for hepatic impairment mirrors similar decisions made last month for extending approved use of the drug for patients with severe renal impairment. Read more.